F-star Therapeutics Announces Publication of Phase 1 Dose Escalation Trial of FS118 in Patients With Advanced PD-L1 Resistant Cancer in Clinical Cancer Research
– FS118 is well tolerated at all dose levels with no serious adverse events related to FS118 therapy
– New mechanism showing an increase in peripheral immune cells and LAG-3 excretion
– 54.8% disease control rate in patients resistant to PD-L1 at doses > 1 mg/kg, including partial response in anaplastic thyroid cancer
– Other ongoing studies in acquired resistance squamous cell carcinoma of the head and neck and naïve non-small cell lung cancer and diffuse B-cell lymphoma
CAMBRIDGE, U.K. and CAMBRIDGE, Mass., Nov. 07, 2022 (GLOBE NEWSWIRE) — F-star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a pioneering biopharmaceutical company bispecific antibodies for immunotherapy so that more people with cancer can live longer and better lives, today announced the publication of safety and efficacy results from the Phase 1 trial of FS118 in patients with advanced cancer resistant to PD-L1 in Clinical cancer researcha journal of the American Association for Cancer Research.
“Phase 1 data published in Clinical cancer research demonstrate that FS118 has the potential to overcome cancer immune resistance given the prolonged pharmacodynamic activity,” said Louis Kayitalire, Chief Medical Officer of F-star. “We are delighted to see that FS118 was well tolerated, and in this population of heavily pretreated patients with acquired PD-L1 resistance, a partial response was achieved and a disease control rate of 54.8% . We look forward to generating additional data and leveraging our bispecific approach to deliver therapies to patients with advanced cancer. »
FS118 is a first-in-class tetravalent bispecific antibody that binds to LAG-3 and PD-L1, resulting in reversal of immune suppression. The Phase 1 trial is the first-in-human study of FS118 that is evaluating forty-three patients with locally advanced/metastatic cancer with a median of three prior treatments and at least one anti-PD-L1 therapy. Patients received intravenous monotherapy of FS118 weekly with an accelerated dose titration design (800 µg to 0.3 mg/kg) followed by a 3+3 escalating dose extension (1 mg/kg to 20 mg/ kg). Weekly dosing was well tolerated with no dose limiting toxicity (DLT) and no serious adverse event (SEA) related to FS118. The recommended phase 2 dose of FS118 has been established at 10 mg/kg per week. Pharmacodynamic activity was prolonged throughout administration, as demonstrated by increased and sustained levels of soluble LAG-3 and peripheral effector cells. A disease control rate (DCR) of 54.8% was observed in patients receiving 1 mg/kg or more who had acquired resistance to PD-L1-targeted therapy.
The article is titled “A First-in-Human Phase 1 Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in PD-L1-Resistant Advanced Cancer Patients.” and is available online at https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-22-1449/710483/A-Phase-1-first-in-human-study-of-FS118-a. The publication’s lead author was Timothy A. Yap of the University of Texas MD Anderson Cancer Center.
F-star’s FS118 is a dual checkpoint inhibitor targeting PD-L1 and LAG-3 that results in LAG-3 excretion and receptor downregulation, via bispecific activity. It is one of a range of dual-antagonist bispecific formats that are being explored in clinical development, each with the potential to elicit a unique biological activity that may result in different clinical outcomes. The unique pharmacology of FS118 potentially offers a longer lasting response in patients. In the Phase 1 clinical trial, FS118 was well tolerated with no serious treatment-related adverse events and no dose-limiting toxicity up to 20 mg/kg.
About F-star Therapeutics, Inc.:
F-star Therapeutics, Inc. is a clinical-stage biopharmaceutical company pioneering bispecific immunotherapy so that more people with cancer can live longer and live better. F-star is committed to working towards a future free of cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. The company has four second-generation immuno-oncology therapies in the clinic, each directed against some of the most promising IO targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property heritage. F-star has over 500 issued patents and pending patent applications relating to its platform technology and product pipeline. The company has attracted several biopharmaceutical partnerships targeting significant unmet needs in several therapeutic areas, including oncology, immunology and CNS. For more information, visit our website and follow us on LinkedIn and Twitter.
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